Efficacy and safety of sitagliptin in patients with type 2 diabetes and ESRD receiving dialysis: a 54-week randomized trial.

Abstract

BACKGROUND:

Treatment with oral antihyperglycemic agents has not been well characterized in patients with type 2 diabetes and end-stage renal disease (ESRD). The efficacy and safety of sitagliptin and glipizide monotherapy in patients with type 2 diabetes and ESRD on dialysis therapy were assessed in this study.

STUDY DESIGN:

54-week, randomized, double-blind, parallel-arm study.

SETTING & PARTICIPANTS:

From 31 clinical sites in 12 countries, 129 patients 30 years or older with type 2 diabetes and ESRD who were on dialysis therapy and had a hemoglobin A1c (HbA1c) level of 7%-9% were randomly assigned 1:1 to treatment.

INTERVENTION:

Monotherapy with sitagliptin, 25 mg daily or glipizide (initiated with 2.5 mg daily and titrated up to a potential maximum dose of 10 mg twice daily or down to avoid hypoglycemia).

OUTCOMES:

Primary end points were 54-week change in HbA1c level from baseline and tolerability with sitagliptin. A secondary end point was the comparison of sitagliptin versus glipizide on the incidence of symptomatic hypoglycemia.

RESULTS:

Of 129 patients randomly assigned, 64 were in the sitagliptin group (mean baseline age, 61 years; HbA1c, 7.9%) and 65 were in the glipizide group (mean baseline age, 59 years; HbA1c, 7.8%). After 54 weeks, the least squares mean change from baseline in HbA1c level was -0.72% (95% CI, -0.95% to -0.48%) with sitagliptin and -0.87% (95% CI, -1.11% to -0.63%) with glipizide, for a difference of 0.15% (95% CI, -0.18% to 0.49%). The incidences of symptomatic hypoglycemia and severe hypoglycemia were 6.3% versus 10.8% (between-group difference, -4.8% [95% CI, -15.7% to 5.6%]) and 0% versus 7.7% (between-group difference, -7.8% [95% CI, -17.1% to -1.9%]) in the sitagliptin and glipizide groups, respectively. Higher incidences (ie, 95% CI around between-treatment difference excluded 0) of cellulitis and headache were found with sitagliptin compared to glipizide (6.3% vs 0%, respectively, for both).

LIMITATIONS:

Small sample size limits between-group comparisons.

CONCLUSIONS:

Treatment with sitagliptin or glipizide monotherapy was effective and well tolerated over 54 weeks in patients with type 2 diabetes and ESRD who were receiving dialysis.

• Authors: Juan C Arjona Ferreira, Dalila Corry, Carl E Mogensen, Lance Sloan, Lei Xu, Gregory T Golm, Edward J Gonzalez, Michael J Davies, Keith D Kaufman, Barry J Goldstein
• Journal: American journal of kidney diseases : the official journal of the National Kidney Foundation (Am J Kidney Dis) Vol. 61 Issue 4 Pg. 579-87 (Apr 2013) ISSN: 1523-6838 [Electronic] United States
• PMID: 23352379 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2013 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Chemical References

• Blood Glucose
• Dipeptidyl-Peptidase IV Inhibitors
• Glycated Hemoglobin A
• Pyrazines
• Triazoles
• Sitagliptin Phosphate

Topics

• Blood Glucose (analysis)
• Diabetes Mellitus, Type 2 (drug therapy)
• Diabetic Nephropathies (drug therapy, therapy)
• Dipeptidyl-Peptidase IV Inhibitors (therapeutic use)
• Double-Blind Method
• Glycated Hemoglobin
• Humans
• Kidney Failure, Chronic (therapy)
• Pyrazines (therapeutic use)
• Renal Dialysis
• Sitagliptin Phosphate
• Triazoles (therapeutic use)